CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 428
- 试验地点
- 2
- 主要终点
- Copenhagen Risk Score
研究概览
简要总结
Schizophrenia is a life shortening disease, not only because of suicide but also because of increased mortality from natural causes. Recently, a large register-based study, involving complete national data from Denmark, Sweden and Finland, showed that life expectancy for schizophrenia is 20 years shorter for men and 15 years shorter for women, compared to the general population, and that mortality from medical conditions and diseases are responsible for a large proportion of the reduced life expectancy. Patients with schizophrenia had a twofold to fivefold increased risk of death by coronary heart disease, respiratory diseases, lung cancer and metabolic conditions. Unhealthy life style and undetected and untreated physical disorders play an important role in this excess mortality.Results from the Danish National Indicator Project for Schizophrenia showed that a much higher proportion of patients with schizophrenia compared to the general population have measures of waist circumference, body mass index, blood pressure, blood lipids and blood glucoses above the recommended upper values.
In the randomized clinical trial CHANGE, the investigators will evaluate the effect of two different interventions both aiming to reduce risk for death from medical diseases. We will compare 1) treatment as usual with 2) affiliation to a care coordinator who has the duty to connect the patient to general practice and primary care and 3) affiliation to a staff member from the CHANGE team who should facilitate life style changes and contact with general practice. The objective is to identify interventions that can reduce the risk of early death in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Affiliated to outpatients services at Mental Health Centre, Copenhagen or Århus University Hospital
- •Diagnose ICD-10:F2 spectrum
- •Waist circumference > 88 cm for women or >102 cm for men
排除标准
- •Not willing to participate
结局指标
主要结局
Copenhagen Risk Score
时间窗: 12 months
The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.
次要结局
- Sedentary lifestyle(12)
- Cholesterol(12 months)
- Aerobic fitness(12 months)
- Body mass index(12 months)
- Blood pressure(12 months)
- Waist circumference(12 months)
- HbA1c(12 months)
- Physical activity(12 months)
- Smoking(12 months)
- Forced expiratory volume(12 months)
- Resting heart rate(12 months)
